Sundent Pharmaceutical Co., Ltd.  

Product Name: Male Latex Condom Ce ISO13485 Best Quality Model NO.: male condom Form: Solid Wearer: Male Type: Contraceptives Material: Glue Colour: Transparent Origin: China Mainland Standard: ISO13485 Trademark: Sundent Transport Package: by Sea by Air Specification: Longth: 180mm, width: 52mm Origin: China HS Code: 4014100000 Product Description SUMMARYPRODUCTINSTRUCTIonThe condom is made by steps of triple dipping, drying, and further vulcanization using pure natural latex rubber that imported from Thailand or Malaysia. There's a latex ring at the open-ended and a teat at the closed end. Between these two ends, it'slatex thin film condom, the surface includes Smooth andNon-Smooth.The condom uses food grade silicone oil as lubricant. And it has a single sealed package.All the condoms passed by 100% individually electronically test. The use of it is contraception or preventing sexually transmitted diseases and AIDS by isolating body fluid contact.2PRODUCT PERFORMANCE ANDREQUIREMENTSThe bursting pressure of single condom(before agingafter aging) ≥ 1.0kpa. The bursting volume of single condom(before agingafter aging) ≥ 18.0dm³, unqualified number of each lot must be controlled within the acceptable range.The pinhole can not be found visible or invisible on a single condom, the unqualified number of pinhole of each lot must be controlled within the acceptable range.The single condom can not have serious visible defects, the unqualified number of visible defects product of each lot must be controlled within the acceptable range.Package integrity shall be measured according to the following protocol using a vacuum level corresponding to (20 ± 5) kPa absolute pressure. The unqualified number of packaging integrity of each lot must be controlled within the acceptable range.The size of single product is allowable in nominal value range. The unqualified number of each lot must be controlled within the acceptable range.The result of Intracutaneous, In Vitro Cytotoxicity and Maximization Sensitization Study must be accordance with biological evaluation standard of medical apparatus and instruments.The single condom should has appropriate penis size, without pinhole, and has enough physical strength that insure it won't break in use. It should have a appropriate packaging for protecting the product init.In the process of normal storage or use, the condom and any lubricant, additive, dressing, packing material or powders in the production process should neither contain nor release enough toxicity, allergies, local irritation or otherhazards.3HOW TOUSE(1)Carefully open the package so the condom does not tear. Do not use the teeth or a sharp object to open the package. Do not unroll the condom before putting iton.(2)Pinching the tip of the condom to squeeze out air, roll on the condom until it reaches the baseofthepenis.Ifthecondomisinitiallyplacedonthepenisbackwards,donotturnitaround. Throw it away and start with a new one.(3)After ejaculation, hold onto the condom at the base of the penis. Keeping the condom on, pull the penis out before it gets soft. Slide the condom off without spilling the liquid(semen) inside. Throw away the usedcondom.(4)The product dose not include spermicide, but have silicone oil lubricant. If you want to use other lubricant, please use the correct type of recommendation, avoid using petroleum base lubricant, such as vaseline, baby oil, bath foam, massage oil, butter, oleomargarine etc. Because these oil can destroy thecondom.(5)Please consult doctor or pharmacist about the applicable drug for touchingcondom.4OBJECTS OF RISKMANAGEMENTThe risk management of whole process of manufacturing of Natural Latex Rubber Condom and during it's storage period.5PURPOSE OF RISKMANAGEMENTThe use of any medical devices will cause some risks. We should always keep the safety and effectiveness of the medical equipment products by managing the risks during the production process and the shelf life, taking effective risk control measures for reducing the risk to an acceptable level.2.CRITERION OF RISKASSESSMENT2.1THE CLASSIFICATION OF RISKSEVERITYThe classification ofseverityDescriptionIllustrateS1UnconspicuousFew or no potential damageNo bad reactionS2SlightCause slight injurySlight bad reactionS3SeriousSerious injury or deathSerious anaphylaxis cause shockor deathS4Very seriousA lot of death or serious injuryCause lots of death2.2THECLASSIFICATIonOFTHERISKPROBABILITYOFOCCURRENCEClassification of harm probabilityDescriptionS6FrequentlyIt will happen one time in use of one hundred timesS5SometimesIt will happen one time in use of one thousand timesS4OccasionalIt will happen one time in use of ten thousand timesS3RarelyIt will happen one time in use of hundred thousandtimesS2Rare occurrenceIt will happen one time in use of million of timesS1Almost impossibleIt will happen one time in use of ten million times2.3THE PRINCIPLE OF ACCEPTABLERISK We'll divide the risk into three region as to harm severity and the probability of harm occurrence: unacceptable area(NAC), widely acceptable area(AC) and reasonable lower area(ALARP).